EP1827604A1 - Verfahren und zusammensetzungen für die adoptive immuntherapie - Google Patents

Verfahren und zusammensetzungen für die adoptive immuntherapie

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Publication number
EP1827604A1
EP1827604A1 EP05815888A EP05815888A EP1827604A1 EP 1827604 A1 EP1827604 A1 EP 1827604A1 EP 05815888 A EP05815888 A EP 05815888A EP 05815888 A EP05815888 A EP 05815888A EP 1827604 A1 EP1827604 A1 EP 1827604A1
Authority
EP
European Patent Office
Prior art keywords
cells
engineered
cell
antigen
subject
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Granted
Application number
EP05815888A
Other languages
English (en)
French (fr)
Other versions
EP1827604B1 (de
EP1827604A4 (de
Inventor
Joseph A. Trapani
Mark J. Smyth
Philip K. Darcy
Michael H. Kershaw
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Peter MacCallum Cancer Institute
Original Assignee
Peter MacCallum Cancer Institute
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=36577617&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=EP1827604(A1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Priority claimed from AU2004907072A external-priority patent/AU2004907072A0/en
Application filed by Peter MacCallum Cancer Institute filed Critical Peter MacCallum Cancer Institute
Priority to EP19151271.4A priority Critical patent/EP3530321A1/de
Publication of EP1827604A1 publication Critical patent/EP1827604A1/de
Publication of EP1827604A4 publication Critical patent/EP1827604A4/de
Application granted granted Critical
Publication of EP1827604B1 publication Critical patent/EP1827604B1/de
Revoked legal-status Critical Current
Anticipated expiration legal-status Critical

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Classifications

    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/32—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against translation products of oncogenes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K39/46—Cellular immunotherapy
    • A61K39/461—Cellular immunotherapy characterised by the cell type used
    • A61K39/4611—T-cells, e.g. tumor infiltrating lymphocytes [TIL], lymphokine-activated killer cells [LAK] or regulatory T cells [Treg]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K39/46—Cellular immunotherapy
    • A61K39/463—Cellular immunotherapy characterised by recombinant expression
    • A61K39/4631—Chimeric Antigen Receptors [CAR]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K39/46—Cellular immunotherapy
    • A61K39/464—Cellular immunotherapy characterised by the antigen targeted or presented
    • A61K39/4643—Vertebrate antigens
    • A61K39/4644—Cancer antigens
    • A61K39/464402—Receptors, cell surface antigens or cell surface determinants
    • A61K39/464403—Receptors for growth factors
    • A61K39/464406—Her-2/neu/ErbB2, Her-3/ErbB3 or Her 4/ ErbB4
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12N—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N5/00—Undifferentiated human, animal or plant cells, e.g. cell lines; Tissues; Cultivation or maintenance thereof; Culture media therefor
    • C12N5/06—Animal cells or tissues; Human cells or tissues
    • C12N5/0602—Vertebrate cells
    • C12N5/0634—Cells from the blood or the immune system
    • C12N5/0636—T lymphocytes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
    • A61K35/12—Materials from mammals; Compositions comprising non-specified tissues or cells; Compositions comprising non-embryonic stem cells; Genetically modified cells
    • A61K2035/124—Materials from mammals; Compositions comprising non-specified tissues or cells; Compositions comprising non-embryonic stem cells; Genetically modified cells the cells being hematopoietic, bone marrow derived or blood cells
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K2039/57—Medicinal preparations containing antigens or antibodies characterised by the type of response, e.g. Th1, Th2
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2239/00—Indexing codes associated with cellular immunotherapy of group A61K39/46
    • A61K2239/31—Indexing codes associated with cellular immunotherapy of group A61K39/46 characterized by the route of administration
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2239/00—Indexing codes associated with cellular immunotherapy of group A61K39/46
    • A61K2239/38—Indexing codes associated with cellular immunotherapy of group A61K39/46 characterised by the dose, timing or administration schedule
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2239/00—Indexing codes associated with cellular immunotherapy of group A61K39/46
    • A61K2239/46—Indexing codes associated with cellular immunotherapy of group A61K39/46 characterised by the cancer treated
    • A61K2239/49—Breast
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2239/00—Indexing codes associated with cellular immunotherapy of group A61K39/46
    • A61K2239/46—Indexing codes associated with cellular immunotherapy of group A61K39/46 characterised by the cancer treated
    • A61K2239/50—Colon
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2239/00—Indexing codes associated with cellular immunotherapy of group A61K39/46
    • A61K2239/46—Indexing codes associated with cellular immunotherapy of group A61K39/46 characterised by the cancer treated
    • A61K2239/55—Lung
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/60—Immunoglobulins specific features characterized by non-natural combinations of immunoglobulin fragments
    • C07K2317/62—Immunoglobulins specific features characterized by non-natural combinations of immunoglobulin fragments comprising only variable region components
    • C07K2317/622—Single chain antibody (scFv)
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2319/00—Fusion polypeptide

Definitions

  • the immune system is designed to target a large number of foreign antigens such as those presented by allergens and pathogens.
  • Immune responses to specific antigens rely on the white bloods cells, and specifically the B cell and T cell populations. B cell responses typically result in the production of antibodies specific to the antigen while T cells are involved in cell mediated responses.
  • T cells are subclassified into two broad populations. Helper T cells are identified by the surface marker CD (Cluster Designation) 4, and are mainly involved in assisting in antibody production and induction of various immune responses. Cytotoxic T cells are distinguished by the CD8 marker and play an important role in recognizing, destroying and eliminating tumor cells and virus- infected cells, but do not produce an antibody specifically reacting with an antigen. Cytotoxic T cells directly recognize and act on antigens (typically antigenic peptides) from a target cell which are associated with major histocompatibility complex (MHC) Class I molecules present on the surface of the target cell membrane.
  • MHC major histocompatibility complex
  • the effective number of engineered CD4+ cells is about 5 x 10 6 and the effective number of engineered CD8+ cells is about 5 x 10 6 .
  • the subject is an adult human, between about 10 10 and 10 11 each of CD4+ and CD8+ cells may be used.
  • the adoptive immune response is capable of preventing establishment of a new tumor or infection.
  • the experiments described herein demonstrate for the first time in vivo that the provision of engineered antigen- specific CD4 + T cells can significantly improve anti-tumor responses, maintain persistence of transferred T cells and induce a potent recall response after tumor rechallenge. This is a substantial advance over the adoptive immunotherapy methods of the prior art.
  • FIG 1 shows expression of the scFv-CD28- ⁇ receptor in transduced CD8 + and CD4 + primary mouse T cells.
  • Splenic T cells enriched from BALB/c mice were depleted into CD4 + and CD8 + T cells subsets or left as unfractionated T cells prior to retroviral transduction with the scFv-CD28- ⁇ receptor.
  • Transduced unfractionated T cells consisted of 80-85% CD8 + T cells and -10% CD4 + T cells (A) while isolated populations consisted of greater than 90% CD8 + (C and G) or QD4- T-cells (i and-l).
  • FIG 3 shows increased transfer of engineered CD4 + T cells enhances tumor- free survival of mice.
  • A Groups of 10 scid mice were injected i.v. with 5x10 6 MDA-MB-435-erbB2 cells at day 0 prior to i.v. injection of scFv-CD28- ⁇ transduced T cells at day 5.
  • mice that received 1 :1 CD4 + (5 x 10 6 ) and CD8 + (5 x 10 6 ) scFv-CD28- ⁇ transduced T cells (A, E and I), unfractionated transduced T cells (10 7 ), mouse #1 (B, C and F), mouse #2 (G, J and K), or 1 :1 CD4 + (5 x 10 6 ) and CD8 + (5 x 10 6 ) scFv- ⁇ -CEA- ⁇ transduced T cells (D, H and L) were stained by H&E, with anti-CD4 (green), anti-CD8 (red) and anti-CD11b (blue) mAbs (E-H) or with anti-tag (red) and anti-CD11 b (green) mAbs (I-L).
  • mice normal scid mice were challenged with 5 x 10 4 4T1.2-erbB2 (closed squares) or 4T1 -parental tumor cells (closed triangles) (D)
  • 4T1.2-erbB2 tumor cells open squares
  • long-term surviving mice were challenged subcutaneously with either 5 x 10 4 cells (open triangles) or 5 x 10 3 4T1.2-erbB2 tumor cells (open squares) and survival was statistically compared (*p ⁇ 0.001 , Mann-Whitney test).
  • the molecule capable of binding to the antigen includes sequences from TCR- ⁇ and/or CD28 co-stimulatory signalling domains, or functional equivalents thereof.
  • Adoptive immunotherapy strategies involving the genetic modification of autologous T cells with scFv chimeric receptors or TCR genes is gaining wider acceptance as a promising treatment for cancer. Indeed, recent advances in the design of scFv receptors comprising both primary TCR- ⁇ and CD28 co-stimulatory signaling domains have demonstrated striking results against early subcutaneous tumor growth and tumor metastases in mice after adoptive transfer (Haynes et al, 2002a; Haynes et al; 2002b).
  • antigen is selected from the group consisting of Le y , EGFR, PMSA, G250, NY-ESO1 , CD20, CD19, idiotype Ig, p53, ras, CEA, MUC1 , GD2, and HuD.
  • antigen is Le y or erbB2.
  • the adoptive immune response leads to the complete eradication of the infection or tumor.
  • the present invention provides a composition for adoptive immunotherapy including an engineered CD4+ T cell and an engineered CD8+ T cell.
  • mice BALB/c and BALB/c scid/scid (scid) mice were purchased from The Walter and Eliza Hall Institute of Medical Research, Melbourne, Australia.
  • BALB/c IFN-Y -deficient mice BALB/c IFN-v " ' " mice were bred at the Peter MacCallum Cancer Centre, Melbourne. Mice of 6 to 12 weeks of age were used in experiments that were performed in accordance with animal experimental ethics committee guidelines.
  • each T cell subset was initially isolated by labelling with anti-CD4 or anti-GD8 ⁇ magnetic- beads (Miltenyi Biotec) and passed-through a-MACS- depletion column. The efficiency of isolating separate T cell subsets was verified by flow cytometry.
  • Enriched CD8 + , CD4 + or unfractionated T cell cultures (10 7 cells) were immediately co-cultured with retrovirus-producing packaging cells (5 x 10 5 ) for 72 h in DMEM supplemented with with 4 ⁇ g/ml polybrene, 5 ⁇ g/ml PHA (Sigma, St Louis, MO) and 100 U/ml rlL-2. Following co-culture, T cells were analysed for transduction efficiency by flow cytometry.
  • Mouse CD8 + , CD4 + or unfractionated T cells (10 6 ) transduced with the scFv- ⁇ -erbB2-CD28- ⁇ receptor or mock CD8 + and CD4 + T cells transduced with an empty LXSN vector were co-cultured with 10 6 erbB2 + MC-38-erbB2, MDA-MB-435-erbB2 or 4T1.2-erbB2 tumor cells or erbB2- MC- 38, MDA-MB-435 or 4T1.2 parental tumor cells in 12-well plates for 20 h. No exogenous IL-2 was added. Supernatants were harvested and IFN- ⁇ , lL-2, GM- CSF, and IL-4 production by transduced T cells was determined by ELISA.
  • EXAMPLE 6 Antigen-specific response to tumor rechallenge.
  • mice An important-issue with -regard to any-cancertherapy is- whether the -specific- treatment can induce a secondary response to tumor relapse.
  • long term surviving mice >100 days
  • transduced CD8 + and CD4 + T cells were injected with an i.v. dose of 5x10 6 MDA-MB-435-erbB2 tumor cells.
  • all mice were able to totally eradicate a second dose of MDA-MB-435-erbB2 tumor (Fig. 6 A).
  • Normal scid mice injected with MDA-MB-435-erbB2 cells did not survive (Fig. 6 A).
  • Gyobu H., T. Tsuji, Y. Suzuki, T. Ohkuri, K. Chamoto, M. Kuroki, H. Miyoshi, Y.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Immunology (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Organic Chemistry (AREA)
  • Cell Biology (AREA)
  • Microbiology (AREA)
  • Animal Behavior & Ethology (AREA)
  • Engineering & Computer Science (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Mycology (AREA)
  • Genetics & Genomics (AREA)
  • Epidemiology (AREA)
  • Biomedical Technology (AREA)
  • Oncology (AREA)
  • Biochemistry (AREA)
  • Zoology (AREA)
  • Wood Science & Technology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Biotechnology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Hematology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Molecular Biology (AREA)
  • General Engineering & Computer Science (AREA)
  • Biophysics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Medicines Containing Material From Animals Or Micro-Organisms (AREA)
EP05815888.2A 2004-12-10 2005-12-12 Verfahren und zusammensetzungen für die adoptive immuntherapie Revoked EP1827604B1 (de)

Priority Applications (1)

Application Number Priority Date Filing Date Title
EP19151271.4A EP3530321A1 (de) 2004-12-10 2005-12-12 Verfahren und zusammensetzungen zur adoptiven immuntherapie

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
AU2004907072A AU2004907072A0 (en) 2004-12-10 Methods and compositions for adoptive immunotherapy
PCT/AU2005/001873 WO2006060878A1 (en) 2004-12-10 2005-12-12 Methods and compositions for adoptive immunotherapy

Related Child Applications (2)

Application Number Title Priority Date Filing Date
EP19151271.4A Division EP3530321A1 (de) 2004-12-10 2005-12-12 Verfahren und zusammensetzungen zur adoptiven immuntherapie
EP19151271.4A Division-Into EP3530321A1 (de) 2004-12-10 2005-12-12 Verfahren und zusammensetzungen zur adoptiven immuntherapie

Publications (3)

Publication Number Publication Date
EP1827604A1 true EP1827604A1 (de) 2007-09-05
EP1827604A4 EP1827604A4 (de) 2009-08-12
EP1827604B1 EP1827604B1 (de) 2019-11-20

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EP19151271.4A Pending EP3530321A1 (de) 2004-12-10 2005-12-12 Verfahren und zusammensetzungen zur adoptiven immuntherapie
EP05815888.2A Revoked EP1827604B1 (de) 2004-12-10 2005-12-12 Verfahren und zusammensetzungen für die adoptive immuntherapie

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Country Status (3)

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EP (2) EP3530321A1 (de)
ES (1) ES2766123T3 (de)
WO (1) WO2006060878A1 (de)

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